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Immune Monitoring and Assay Development in Organ Transplant Recipients (IMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01283295
Recruitment Status : Recruiting
First Posted : January 25, 2011
Last Update Posted : August 22, 2018
Information provided by (Responsible Party):
Aneesh K. Mehta, Emory University

Brief Summary:
The purpose of this study to develop a well-characterized library of blood, biopsy tissue, and urine samples from transplant patients. Subjects without transplants will also be enrolled for comparison. Samples will be used to study the characteristics of patients undergoing transplantation that influence their response to transplant therapies and their reactions to drugs used in transplantation. This knowledge is important as it helps physicians design new drugs and tailor transplant therapies to the individual thereby reducing the side effects. In this study, people will be asked to donate blood, biopsy tissue and urine. Donation of these samples will not influence patients' treatments. These samples will be tested using a variety of biological tests to better understand how immunosuppressive drugs change the various components of the immune system. The tests will be for research only; no changes in an individual's treatment will be based on the results of tests performed in this study. If there is extra sample, the sample will be stored for use in other testing at a later date. The ultimate goal is find the right combination of medications for each individual patient while keeping their new organ working well. This study is a first step in that direction by perfecting tests used to characterize a patient's immune system

Condition or disease
Organ Transplantation Transplantation Immunology

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Monitoring and Assay Development in Organ Transplant Recipients
Study Start Date : November 2007
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Immune complications
Transplant recipients who develop a clinically recognized complication with potential immune etiology or ramifications. Examples include opportunistic infection, rejection, malignancy, alloantibody formation or immunosuppressive drug toxicity.
Stable Transplant Recipient
Patients who demonstrate immune stability characterized by stable graft function without evident complication. These patients serve as comparators for Group 1
Pre-Transplant Longitudinal
Patients who are candidates for kidney, pancreas, liver or lung transplant will be enrolled and followed longitudinally.
Organ Donors
Donors for individuals meeting the criteria for Cohorts 1-3
Disease state
Individuals with liver, renal or pulmonary diseases that may lead to the development or organ failure.
Normal Volunteers

Primary Outcome Measures :
  1. To generate a bank of well-characterized biological samples from human subjects prior to or following organ transplantation for the purpose of subsequent evaluation using new and existing immunological assays [ Time Frame: Ongoing ]

Biospecimen Retention:   Samples With DNA
PBMCs, serum, urine, kidney and liver biopsy samples, broncheolar lavage fluid

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
pediatric or adult organ transplant recipients, candidates for organ transplant, donors and normal volunteers of Emory University Hospital, the Emory Transplant Center or Children's Healthcare of Atlanta (CHOA)

Inclusion Criteria:

  • recipients of or candidates for organ transplantation or organ donors for recipients under evaluation at Emory University or CHOA
  • normal volunteers, including individuals without any known end-stage organ disease who are not on any immunosuppressive medication, and individuals with conditions requiring immunosuppression (i.e. dermatological diseases) that do not require transplant therapies
  • ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of minors, ability to give minor assent (children older than 5 years of age), in conjunction with written guardian consent

Exclusion Criteria:

  • patients who fail to meet the criteria for transplantation or post-transplant follow-up by Emory or Childrens Healthcare of Atlanta physicians
  • Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions include but are not limited to: anemia prohibitive of phlebotomy, coagulopathy or technical considerations that would prevent acquisition of sufficient tissue on biopsy for clinical use, or medical urgency preventing timely administration of the consenting process.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01283295

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Contact: Shine Thomas, CRC 404-712-2004

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United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Tauri Harden, CRC         
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
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Principal Investigator: Aneesh K Mehta, MD Emory University

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Responsible Party: Aneesh K. Mehta, Associate Professor, Emory University Identifier: NCT01283295     History of Changes
Other Study ID Numbers: IRB00006248
IMP ( Other Identifier: Other )
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018